UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014747 |
|---|---|
| Receipt number | R000017145 |
| Scientific Title | The effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled trial. |
| Date of disclosure of the study information | 2014/08/02 |
| Last modified on | 2016/09/14 11:35:54 |
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Basic information
Public title
The effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled trial.
Acronym
The effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled trial.
Scientific Title
The effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled trial.
Scientific Title:Acronym
The effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus: A randomized controlled trial.
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effectiveness of text message based health literacy on medication adherence in patients with type 2 diabetes mellitus at 6 months.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change in medication adherence from baseline to 6 months.
Key secondary outcomes
Change or percent change in following items from baseline to 1, 3, 6 months.
1) Medication adherence
2) Health literacy
3) HbA1c
4) self efficacy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Received biweekly text messages on their cellphones to take their medication and improve their health literacy for 6 months.
Interventions/Control_2
Received biweekly text messages on their cellphones to only take their medication for 6 months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese.
2) Age >=18 years old.
3) The reason of hospitalization is to take the education of diabetes.
4) HbA1c >= 6.5%.
5) Taking oral medications or injectable medication.
6) To be able to get and access text messages on their cell phone.
7) Don't be diagnosed the depression.
8) Received informed consent.
Key exclusion criteria
No consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Sugita |
Organization
Showa University
Division name
School of Pharmacy, Department of Hospital Pharmaceutics
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8467
hsugita@cmed.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Sugita |
Organization
Showa University
Division name
School of Pharmacy, Department of Hospital Pharmaceutics
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8467
Homepage URL
hsugita@cmed.showa-u.ac.jp
Sponsor or person
Institute
Department of Health Sciences, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Health Sciences, Interdisciplinary Graduate School of Medicine and Engineering, University of Yamanashi, Japan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山梨大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 02 | Day |
Last modified on
| 2016 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017145
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
